First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors

Recruiting now · Phase 1

Conditions studied: Select Advanced Solid Tumors

In brief

CDR404 is a highly potent and specific T-cell engaging bispecific and bivalent antibody designed for the treatment of cancers positive for the tumor-associated antigen melanoma-associated antigen 4 (MAGE-A4). This is a first-in-human study designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of CDR404 in adult patients who have the appropriate germline human leukocyte antigen HLA-A\*02:01 tissue marker and whose cancer is positive for MAGE-A4.

Key facts

Study ID

NCT06402201

Run by

CDR-Life AG

People needed

42

Starts

2024-05-24

Expected to finish

2027-12-31

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of written informed consent
• HLA-A*02:01 positive
• MAGE-A4 positive tumor
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) [ECOG PS] 0 or 1
• Selected advanced solid tumors
• Relapsed from, refractory to, or intolerant of standard therapy
• Measurable disease per RECIST v1.1
• Adequate organ function
• If applicable, must agree to use highly effective contraception

You may not qualify if…

• Symptomatic or untreated central nervous system metastasis
• Inadequate washout from prior anticancer therapy
• Significant ongoing toxicity from prior anticancer treatment
• Recent surgery
• Clinically significant cardiac disease
• Active infection requiring systemic antibiotic treatment
• Human immunodeficiency virus (HIV) at risk of acquired immunodeficiency syndrome (AIDS)-related outcomes
• Active hepatitis B virus (HBV) or hepatitis C virus (HBC)
• Ongoing treatment with systemic steroids or other immunosuppressive therapies
• Significant secondary malignancy
• History of chronic or recurrent active autoimmune disease requiring treatment
• Uncontrolled intercurrent illness
• Pregnancy or lactation.

Where it is running

• University of Miami — Miami, Florida, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Providence Cancer Institute — Portland, Oregon, United States (enrolling)
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States (enrolling)
• Universitair Ziekenhuis Antwerpen — Antwerp, Belgium (enrolling)
• Institut Jules Bordet — Brussels, Belgium (enrolling)
• Cliniques Universitaires Saint-Luc, UCL Ouvain — Brussels, Belgium (enrolling)
• Universitair Ziekenhuis Gent — Ghent, Belgium (enrolling)
• Rigshospitalet — Copenhagen, Denmark (enrolling)
• Istituto Clinico Humanitas — Milan, Italy (enrolling)
• Isituto Europeo di Oncologia (IEO) — Milan, Italy (enrolling)
• Hospital Universitari Vall d'Hebron — Barcelona, Spain (enrolling)
• Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO) — Barcelona, Spain (enrolling)
• Hospital 12 de Octubre — Madrid, Spain (enrolling)
• START Madrid — Madrid, Spain (enrolling)
• Hospital Universitari i Politecnic La Fe — Valencia, Spain (enrolling)
• Instituto de Investigacion Sanitaria (INCLIVA) — Valencia, Spain (enrolling)
• Royal Marsden Hospital — Sutton, London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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